Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY

Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY: A Prospective Multicenter Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01856504

Acronym

VICTORY

Enrollment

218

Registered

2013-05-17

Start date

2013-05-31

Completion date

2015-03-31

Last updated

2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Arteriosclerosis, Coronary Artery Disease

Keywords

Heart Disease, Coronary Artery Disease, Coronary Arteriosclerosis

Brief summary

To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.

Detailed description

Hypothesis: Coronary CT angiography (CCTA) employing a novel intracycle motion compensation algorithm (SnapShot Freeze \[SSF\]) will be superior to CCTA without an intracycle motion compensation algorithm (conventional CCTA) for diagnostic accuracy and image quality. Scientific Basis: Preliminary study (Leipsic, Min, Journal of Cardiovascular Computed Tomography \[in press\]) of coronary CT angiograms in individuals undergoing pre-procedural assessment for transcatheter aortic valve replacement (n=36) demonstrate improved image quality of CCTA using SSF compared to CCTA not using SSF. Importantly, individuals in this study did not receive heart rate slowing agents (e.g., beta blockers), and diagnostic image quality was substantially improved. While not statistically powered on a per-patient basis, per-segment diagnostic accuracy of CCTA using SSF was superior to conventional CCTA. These results are complementary to those derived from internal testing at GE Healthcare wherein phantom work has demonstrated improved diagnostic performance using SSF compared to conventional image acquisitions. Long-term Goal/Purpose: To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy. If the aims of this study are achieved, the use of SSF for effective temporal resolution improvement may obviate (or reduce) the need for CT hardware for improved temporal resolution.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Consenting adult patients ≥18 years of age; 2. Suspected but without known prior history of CAD 3. Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin) 4. Glomerular filtration rate \>60 ml/min 5. CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization)

Exclusion criteria

1. Incomplete ICA or CCTA; 2. Known CAD (prior myocardial infarction, PCI, CABG) 3. Atrial Fibrillation 4. Abnormal Renal Function (GFR \<60 ml/min) 5. Unwilling or unable to give consent 6. Non-cardiac illness with life expectancy \<1 year 7. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device 8. Pregnant women 9. Allergy to iodinated contrast agent 10. Contraindications to nitroglycerin 11. Systolic blood pressure ≤90 mm Hg 12. Contraindications to β blockers or nitroglycerin

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Accuracy	30 days	To compare the per-patient, per-vessel and per-segment diagnostic accuracy of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
Diagnostic Interpretability	30 days	To compare the per-patient, per-vessel and per-segment diagnostic interpretability of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
Image quality	30 day	To compare the per-patient, per-vessel and per-segment quantitative image quality of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.

Secondary

Measure	Time frame	Description
Upper threshold of heart rate	1 day	To determine the upper threshold of heart rate below which CCTA with SSF is most effective.
incremental & additive value	1 day	To determine the incremental & additive value of SSF to conventional CCTA for diagnostic accuracy / diagnostic interpretability / image quality.

Countries

Argentina, Canada, India, Italy, United States

Outcome results